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Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries

IMPORTANCE: Many randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle–income countries (LMICs) and upper middle–income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which c...

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Autores principales: Rubagumya, Fidel, Hopman, Wilma M., Gyawali, Bishal, Mukherji, Deborah, Hammad, Nazik, Pramesh, C. S., Zubaryev, Mykola, Eniu, Alexandru, Tsunoda, Audrey T., Kutluk, Tezer, Aggarwal, Ajay, Sullivan, Richard, Booth, Christopher M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389348/
https://www.ncbi.nlm.nih.gov/pubmed/35980637
http://dx.doi.org/10.1001/jamanetworkopen.2022.27252
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author Rubagumya, Fidel
Hopman, Wilma M.
Gyawali, Bishal
Mukherji, Deborah
Hammad, Nazik
Pramesh, C. S.
Zubaryev, Mykola
Eniu, Alexandru
Tsunoda, Audrey T.
Kutluk, Tezer
Aggarwal, Ajay
Sullivan, Richard
Booth, Christopher M.
author_facet Rubagumya, Fidel
Hopman, Wilma M.
Gyawali, Bishal
Mukherji, Deborah
Hammad, Nazik
Pramesh, C. S.
Zubaryev, Mykola
Eniu, Alexandru
Tsunoda, Audrey T.
Kutluk, Tezer
Aggarwal, Ajay
Sullivan, Richard
Booth, Christopher M.
author_sort Rubagumya, Fidel
collection PubMed
description IMPORTANCE: Many randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle–income countries (LMICs) and upper middle–income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research. OBJECTIVE: To describe which UMICs and LMICs participate in RCTs led by HICs. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022. MAIN OUTCOMES AND MEASURES: A bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC). RESULTS: Among the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output). CONCLUSIONS AND RELEVANCE: In this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study.
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spelling pubmed-93893482022-09-06 Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries Rubagumya, Fidel Hopman, Wilma M. Gyawali, Bishal Mukherji, Deborah Hammad, Nazik Pramesh, C. S. Zubaryev, Mykola Eniu, Alexandru Tsunoda, Audrey T. Kutluk, Tezer Aggarwal, Ajay Sullivan, Richard Booth, Christopher M. JAMA Netw Open Original Investigation IMPORTANCE: Many randomized clinical trials (RCTs) led by high-income countries (HICs) now enroll patients from lower middle–income countries (LMICs) and upper middle–income countries (UMICs). Although enrolling diverse populations promotes research collaborations, there are issues regarding which countries participate in RCTs and how this participation may contribute to global research. OBJECTIVE: To describe which UMICs and LMICs participate in RCTs led by HICs. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study of all oncology RCTs published globally during January 1, 2014, to December 31, 2017, was conducted. The study cohort was restricted to RCTs led by HICs that enrolled participants from LMICs and UMICs. Study analyses were conducted in November 1, 2021, to May 31, 2022. MAIN OUTCOMES AND MEASURES: A bibliometric approach (Web of Science 2007-2017) was used to explore whether RCT participation was proportional to other measures of cancer research activity. Participation in RCTs (ie, percentage of RCTs in the cohort in which each LMIC and UMIC participated) was compared with country-level cancer research bibliometric output (ie, percentage of total cancer research bibliometric output from the same group of countries that came from a specific LMIC and UMIC). RESULTS: Among the 636 HIC-led RCTs, 186 trials (29%) enrolled patients in LMICs (n = 84 trials involving 11 LMICs) and/or UMICs (n = 181 trials involving 26 UMICs). The most common participating LMICs were India (42 [50%]), Ukraine (39 [46%]), Philippines (23 [27%]), and Egypt (12 [14%]). The most common participating UMICs were Russia (115 [64%]), Brazil (94 [52%]), Romania (62 [34%]), China (56 [31%]), Mexico (56 [31%]), and South Africa (54 [30%]). Several LMICs are overrepresented in the cohort of RCTs based on proportional cancer research bibliometric output: Ukraine (46% of RCTs but 2% of cancer research bibliometric output), Philippines (27% RCTs, 1% output), and Georgia (8% RCTs, 0.2% output). Overrepresented UMICs include Russia (64% RCTs, 2% output), Romania (34% RCTs, 2% output), Mexico (31% RCTs, 2% output), and South Africa (30% RCTs, 1% output). CONCLUSIONS AND RELEVANCE: In this cross-sectional study, a substantial proportion of RCTs led by HICs enrolled patients in LMICs and UMICs. The LMICs and UMICs that participated in these trials did not match overall cancer bibliometric output as a surrogate for research ecosystem maturity. Reasons for this apparent discordance and how these data may inform future capacity-strengthening activities require further study. American Medical Association 2022-08-18 /pmc/articles/PMC9389348/ /pubmed/35980637 http://dx.doi.org/10.1001/jamanetworkopen.2022.27252 Text en Copyright 2022 Rubagumya F et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Rubagumya, Fidel
Hopman, Wilma M.
Gyawali, Bishal
Mukherji, Deborah
Hammad, Nazik
Pramesh, C. S.
Zubaryev, Mykola
Eniu, Alexandru
Tsunoda, Audrey T.
Kutluk, Tezer
Aggarwal, Ajay
Sullivan, Richard
Booth, Christopher M.
Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title_full Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title_fullStr Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title_full_unstemmed Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title_short Participation of Lower and Upper Middle–Income Countries in Clinical Trials Led by High-Income Countries
title_sort participation of lower and upper middle–income countries in clinical trials led by high-income countries
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9389348/
https://www.ncbi.nlm.nih.gov/pubmed/35980637
http://dx.doi.org/10.1001/jamanetworkopen.2022.27252
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